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USP opens expanded Indian testing lab

By Gareth Macdonald , 05-Sep-2011
Last updated on 05-Sep-2011 at 14:03 GMT2011-09-05T14:03:21Z

The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.

The US pharmaceutical standards organisation has added over 80,000sqft of floor space at the laboratory, which is at the heart of the city’s IKP Knowledge Park, and plans to hire an additional 20 scientific staff over the next 12-months.

Roger Williams, USP CEO, said: “This expands our scope considerably. We are now to do more collaborative testing, verification testing, pharmacopeial education, customer support and sourcing of written and physical stands for drugs.”

A key part of this work will be the production of reference materials for the USP’s recently launched Medicines Compendium, which is a freely available portfolio of testing standards, procedures and critical quality attributes for drugs and active pharmaceutical ingredients (APIs).

Dr Williams also explained that, in addition to providing pharmaceutical quality testing services and knowhow, the expanded laboratory will be a base for the USP’s synthetic and bioanalytical chemistry standards initiatives and play a role in dietary supplement analysis.

The USP has operated in Hyderabad site since 2006 when it opened the lab, at the time its first outside the US, after signing a memorandum of understanding (MoU) with the Indian Pharmacopoeia Commission (IPC) intended to raise “awareness of the importance of the quality and safety of medicines. “

BRIC expansion

The USP’s focus on India fits with the widely held belief that manufacturers in the country will play an increasingly important role in producing pharmaceuticals for the global market.

Speaking last month at Confederation of Indian Industry (CII) event Indian health Minister Sudip Bandyopadhyay said: “The next few years are going to spell big opportunity for Indian pharmaceutical companies with an estimated 61 drugs worth over $80bn reportedly going off the list of US Patent and Trademark Office (USPTO) between 2011 and 2013.

This was echoed by CII chairman Satish Reddy who said: “Indian firms produce about 60,000 generic brands across 60 therapeutic categories. India is also among the world’s leading five producers of active pharmaceutical ingredients (API), while in formulations India is the second largest producer in the world.”

The Hyderabad expansion also follows just weeks after the USP opened its first testing facility in Brazil and is a further indication of the importance of BRIC (Brazil, Indian, Russia and China) to the global pharmaceutical sector.

The USP was unable to respond to requests for additional information ahead of publication.

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